The Role Of Fructose and Uric Acid In the Development of Obesity and Metabolic Syndrome

National Institute of Cardiology Ignacio Chavez

Status: Completed

Conditions: Hyperuricemia; Overweight and Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: low fructose; Dietary Supplement: Normal fructose arm

Study type: Interventional

Funder types: Other

Identifiers

NCT00868673

FRUCTOSE 09-630

Details and patient eligibility

About

The purpose of this study is to determine if a low fructose intake could have an impact on weight loss, uric acid levels and the components of the metabolic syndrome (glucose, cholesterol, triglycerides, insulin resistance, high blood pressure).

Full description

Overweight and obesity are now considered a growing public health problem in Mexico and worldwide. This epidemic has been attributed to dietary fructose consumption. Although experimental models have demonstrated a role of fructose in the development of obesity, metabolic syndrome and kidney disease, data in human models is lacking. The purpose of this study is to determine if a low fructose intake could have an impact on the components of the metabolic syndrome. The primary endpoint will be to determine the impact of low fructose on weight loss. Secondary endpoints will evaluate the impact of low fructose diet on blood pressure and cardiovascular biochemical profile.

If fructose is a causal pathway to obesity and metabolic syndrome, it may represent an important target to mitigate this important health problem.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals with a Body Mass Index (BMI) > 25. BMI defined as: Weight in kilograms divided by Height (squared) in meters.
• Residents of Mexico city
• Healthy individuals (no comorbidities or drug prescription for associated chronic diseases)

Exclusion criteria

• Diabetes Mellitus Type 1 or 2
• Severe Hypertension (defined as systolic blood pressure > 160 mmHg and /or diastolic blood pressure > 100 mmHg) and/or Hypertension on pharmacological treatment.
• Chronic Kidney Disease (Glomerular Filtration Rate (GFR) < 60 ml/min)
• Hepatic Damage or Advanced Disease (clinical, biochemical or histological)
• Patient receiving any pharmacological treatments for hypercholesterolemia and/or elevated triglycerides.
• Anemia (any etiology)
• Malignancy
• Pregnancy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Low fructose arm

Active Comparator group

Description:

Overweighted or obese previously healthy adults (with no other comorbidities, defined as: Diabetes (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of \>25 kilograms(weight)/ squared meters (height). They will be randomized to a 1500, 1800 or 2000 kilocalories diet calculated by Harris Benedict equation, thermic effect of foods and rest energy (without exercise). This group will be assigned to a 2 week period of low fructose diet (less than 10 grams/day ) followed by a 4 week period of less than 20 grams/day fructose diet levels. Total Time of intervention 6 weeks for each patient

Treatment:

Dietary Supplement: low fructose

Normal fructose arm

Active Comparator group

Description:

Overweighted or obese previously healthy adults (with no other comorbidities; defined as: Diabetes Mellitus (DM1 or DM2), hypertension, chronic kidney disease (CKD), hepatic damage, dyslipidemia medication, anemia, malignancy or pregnancy), with a Body Mass Index (BMI) of \>25 kilograms(weight)/ squared meters (height). Participants will be randomized to a 1500, 1800 or 2000 kilocalories diet (of 15% proteins, 30% lipids and 55% carbohydrates); calculated by Harris Benedict equation, thermic effect of foods and energy (without exercise). This group will receive a controlled fructose diet between 50 and 70 grams/day of fructose intake. Total time of intervention:6 weeks for each patient

Treatment:

Dietary Supplement: Normal fructose arm